eSource and eCTD Guidance & Eliminating Shadow Charts: Is Now the Time?

Shadow charts develop for various reasons in clinical research as discussed in a prior post on shadow charts. They emerge at trial sites because of disparate IT systems: for example an EHR record may be printed onto paper for editing, redacting and signing before being rescanned into a study portal. The remaining stub is a shadow chart.

Other times shadow charts bloom because an original form was unavailable during a patient visit— a duplicate is created on the spot instead.

Sponsors, too, produce their own shadow charts. For example, monitoring teams end up creating copies of documents in shared drives and email to keep up with tasks.

Why worry? Shadow charts drag two material problems long with them: 1) They create additional document editing chores as being able to work with a digital original 2) Duplicate versions of the same trial document create confusion, run against Good Clinical Practice audit guidelines and create audit risk.

The answer is “yes.” There is a wave of electronic guidance from the FDA and ICH that paves the way for elimination of both site and sponsor shadow charts by implementing centralized electronic systems.

The FDA eSource guidance is focused on setting a foundation for electronic direct and indirect source data capture. This guidance has two primary impacts:

For sites: Meanwhile, FDA & ICH eSource guidance allows sites to make a compliant transition to digital site file, regulatory and source management. The eSource guidance and the eCTD guideline address the electronic clinical trial process from both ends of the trial marketplace.

What about worldwide? By echoing FDA guidance, the recent ICH E6 R2 revision draft shows that the entire trial community can make electronic processes standard. The R2 draft focuses on how to apply computerized systems from end-to-end for sponsors, CROs, and sites and builds on FDA guidance by further exploring risk based monitoring and eSource strategies.

Recommendations

The regulatory environment is in place. By transitioning document work to a digital standard, and by adopting a system that lets sites and sponsors work in the same place, the industry is on the verge of finally moving past shadow charts. The next step is for sponsors and sites to implement a single platform for clinical trial documents that works for all parties.